Pinto Gouveia M, Gameiro A, Pinho A, Gonçalo M
Dermatology Department, Coimbra University Hospital Centre, Coimbra, Portugal.
Clinic of Dermatology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
Clin Exp Dermatol. 2017 Oct;42(7):735-742. doi: 10.1111/ced.13173. Epub 2017 Jun 25.
Clinical trials have shown the efficacy of omalizumabs efficacy in refractory chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), but real-life management strategies are lacking.
To assess the long-term efficacy and safety of omalizumab, and to identify predictive factors and optimum dosage regimens.
This was a prospective study of 13 patients (11 women, 2 men) with severe CSU [weekly urticaria activity score (UAS7) > 28] resistant to anti-H1 antihistamines. Patients were started on omalizumab 150 mg subcutaneously every 4 weeks. Dose and interval between administrations were adjusted according to clinical response (189 administrations; treatment duration range 2-38 months).
Mean UAS7 was 36.3 ± 5.4. Of the 13 patients, all had experienced angio-oedema, while in addition, 7 had delayed pressure urticaria (DPU) and 1 had solar urticaria (SU). After omalizumab treatment, 4 (30.8%) of the 13 patients had complete response (CR), and the remaining 8 (61.5%) had partial response. CR was achieved with a dose of 150 mg every 4 (n = 2 patients) or 5 (n = 2) weeks. One of these patients remained disease-free after stopping treatment. Partial responses were achieved with 150 mg every 4 weeks (n = 4) and with 300 mg (n = 4) at intervals of 5 weeks (n = 1), 4 weeks (n = 2) or 3 weeks (n = 1). Only one patient (7.7%) did not show significant improvement, despite a dose of 300 mg every 4 weeks. There were no significant differences in epidemiological, clinical and laboratory data between the different response groups. Only two adverse events were observed: one was mild headache and the other was severe angio-oedema and aggravation of urticaria within 6 h of omalizumab administration.
Omalizumab dose and interval between administrations could be individualized for long-term management of CSU.
临床试验已显示奥马珠单抗在难治性慢性自发性荨麻疹（CSU）和慢性诱导性荨麻疹（CIndU）中的疗效，但缺乏实际应用中的管理策略。
评估奥马珠单抗的长期疗效和安全性，并确定预测因素和最佳给药方案。
这是一项对13例（11例女性，2例男性）对抗H1抗组胺药耐药的重度CSU患者[每周荨麻疹活动评分（UAS7）>28]进行的前瞻性研究。患者开始每4周皮下注射150mg奥马珠单抗。根据临床反应调整剂量和给药间隔（共189次给药；治疗持续时间为2 - 38个月）。
平均UAS7为36.3±5.4。13例患者中，均有血管性水肿，此外，7例有迟发性压力性荨麻疹（DPU），1例有日光性荨麻疹（SU）。奥马珠单抗治疗后，13例患者中有4例（30.8%）完全缓解（CR），其余8例（61.5%）部分缓解。每4周（n = 2例患者）或5周（n = 2例）注射150mg实现了完全缓解。其中1例患者停药后无疾病复发。每4周注射150mg（n = 4例）以及每5周（n = 1例）、4周（n = 2例）或3周（n = 1例）注射300mg实现了部分缓解。尽管每4周注射300mg，但只有1例患者（7.7%）未显示出明显改善。不同反应组之间在流行病学、临床和实验室数据方面无显著差异。仅观察到两例不良事件：一例为轻度头痛，另一例为在注射奥马珠单抗后6小时内出现严重血管性水肿和荨麻疹加重。
奥马珠单抗的剂量和给药间隔可个体化用于CSU的长期管理。
